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Stent Thrombosis: Implications for New Stent Designs and Dual Antiplatelet Therapy Duration Chapter | 16 243
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noncardiac surgical procedure [84]. The risk of DAPT cessation for surgical procedures may differ for DES or BMS. For
example, the risk of a major adverse coronary event was greatest following BMS deployment when surgery was performed
at <30 days (odds ratio [OR] 4.0; P < .001) but remained high when surgery was performed at 31 e 90 days (OR 1.4;
P < .001) compared with 91 days [89]. Conversely, patients having noncardiac surgery 1e2 months following 2GDES
deployment had no apparent incremental risk for cardiac death or MI compared with patients without ischemic heart
disease having the same surgical procedure [90]. A large observational series with propensity mat ching demonstrated an
increased incidence of major adverse cardiovascular events when DAPT was discontinued for noncardiac surgery between
6 weeks and 6 months following PCI with a BMS compared with newer generation DESs [91]. Although the relative
hazard of adverse events following DAPT discontinuation for noncardiac surgical procedures in BMS (vs. DES)-treated
patients is counter to conventional perceptions and current consensus guideline recommendations, this observation has
been consistent across multiple data sets, and suggests the need for guideline revision. In aggregate, these data suggest that
noncardiac surgery should be deferred at least 6 weeks to 3 months following stent deployment, especially in patients
treated for ACS, regardless of stent type (DES or BMS). These data also support the practice of abbreviated and partial
DAPT discontinuation, if possible, as has been recommended [92]. This practice involves stopping the P2Y12 receptor
antagonist (clopidogrel or ticagrelor at 5 days, prasugrel at 7 days) before surgery and restarting these agents within
48e72 h postoperatively. Aspirin (81 mg daily) therapy should not be discontinued if at all possible. Consideration may be
given to reloading patients at greatest risk for ST (history of ACS, prior bifurcation stenting or vascular brachytherapy)
with the P2Y12 receptor inhibitor following the noncardiac surgical procedure.
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Chapter 17
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Aspiration Catheters and Protection
Filters
Dhruv Mahtta, Islam Y. Elgendy, Ahmed N. Mahmoud and Anthony A. Bavry
University of Florida, Gainesville, FL, United States
INTRODUCTION
Plaque rupture and subsequent partial or complete occlusion of a coronary artery is a well-known pathophysiological event
that takes place during an acute ST-segment elevation myocardial infarction (STEMI). The vast majority of STEMI
patients undergoing primary percutaneous coronary intervention (PPCI) are found to have intracoronary thrombus burden,
and approximately 30% are found to have a large intracoronary thrombus (i.e., defined as greater than or equal to 2 times
the vessel diameter) [1]. Not only does thrombus compromise antegrade flow, but distal embolization of thrombus can lead
to mechanical obstruction of microvasculature, platelet activation with subsequent thrombosis due to tissue factor release,
and microvascular spasm due to the release of thromboxane and other vasoactive agents. Several studies in the past have
thoroughly demonstrated the negative prognostic effect of the presence of intracoronary thrombus during PPCI. A strong
association exists between angiographic evidence of intracoronary thrombus and higher incidence of major adverse cardiac
events (MACEs), embolization of debris, no-reflow phenomenon, stent thrombosis, and transmural myocardial damage
[2e4]. Over the years, several pharmacological agents, stenting approaches, and devices have been developed for better
management of coronary thrombus. Aspiration thrombectomy, mechanical thrombectomy, and embolic protection devices
(EPDs) have been developed and well studied to aid in the removal of coronary thrombus. In this chapter, we will review
aspiration thrombectomy as well as EPDs and discuss the clinical evidence as it relates to their use.
ASPIRATION THROMBECTOMY
Percutaneous Aspiration Thrombectomy Catheter System
The very first aspiration thrombectomy catheter system was developed and patented by Auth and colleagues in 1995 [5].
This catheter system entails a proximal end and a distal end, which is designed such that it could easily be advanced over a
guidewire for placement proximal to a thrombus. This distal end also consists of radiopaque markers, which aid in
visibility under fluoroscopy, as well as an angled tip to reduce the propensity to clog the lumen during thrombus retrieval.
The proximal end of the catheter system is attached to a suction device, which varies from a mechanical syringe to an
automated vacuum suction device. After advancement of the catheter syst em over the guidewire, the distal end of the
catheter comes into fluid contact with the targeted thrombus, at which point suction is applied. With the continued suction,
the catheter is advanced distally through the thrombus to allow complete retrieval of the thrombus. The aspiration catheter
is then gradually withdrawn while the suction force is continued until the catheter and retrieved thrombus are out of the
guidewire.
Since the development of the very first aspiration catheter system, designs have evolved over the years and newer
systems have incorporated different tips, lumen sizes, and mouth designs to better engage and retrieve the thrombus. The
development of different designs of aspiration catheter is aimed at creating an ideal system in which the stiffness varies
depending on the region of the catheter. The proximal end is preferred to be stiffer, thus allowing sufficient pushing ability.
Cardiovascular Thrombus. https://doi.org/10.1016/B978-0-12-812615-8.00017-X
Copyright © 2018 Elsevier Inc. All rights reserved.
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FIGURE 17.1 Export Advance catheterdaspiration thrombectomy device. Image provided courtesy of Medtronic. © 2017 Medtronic Corporation or
its affiliates. All rights reserved.
TABLE 17.1 Aspiration Thrombectomy Devices
Device Name Manufacturer Guide Catheter (Fr)
Export AP Medtronic 6, 7
Export Advance Medtronic 6, 7
Priority One Terumo 6, 7
Pronto V3 Vascular Solutions 6
Pronto V4 Vascular Solutions 6, 7, 8
Pronto LP Vascular Solutions 6
ExpressWay Maquet 6
QuickCat Spectranetics 6
Fetch 2 Bayer 6
The midsection is preferred to have medium stiffness, which allows the operator to easily navigate through tortuous
vasculature. Last, the dist al end of the catheter consists of a hydrophilic coated flexible end, which allows the least amount
of drag and damage to the vessel when navigating and positioning the catheter near the target coronary lesion. All these
components cumulate in making an ideal aspiration catheter, which, when manipulated by an experienced operator, is able
to be rapidly exchanged over the guidewire, expeditiously reach the target lesion, and effectively aspirate the thrombus
debris (Fig. 17.1).
The catheter lumen diameter had been a topic of debate. Although, theoretically a large-lumen catheter was thought to
be more efficient in aspirating thrombus material, the larger lumen size may cause hindrance in device handling and safety.
Broadly, lumen sizes are categorized into large-, medium-, and small-lumen aspiration catheters. Large-lumen catheters
consist of the Diver (0.062 in.) and Pronto (0.065 in.) catheter systems. The Export (0.041 in.) and Rescue (0.042 in.)
catheter systems are classified as medium-sized lumen catheters, while the Probing aspiration catheter set (0.018 in.) is
considered a small-lumen aspiration catheter. Vlaar and colleagues conducted a prospective cohort study to determine the
influence of catheter lumen diameter (large vs. medium size) on the effectiveness of thrombus aspiration in STEMI
patients. Their findings demonstrated that the larger internal lumen diameter catheter did not result in aspiration of larger
thrombus material, nor was there any evidence of improved angiographic (myocardial blush grade) or electrocardiographic
outcomes between the types of devices [6]. Equal effectiveness of large- versus medi um-sized catheter systems is thought
be due to the freshly formed, friable thrombus in STEMI patients, which is able to be retrieved equally as well through a
medium catheter as through a large catheter (Table 17.1).
Use of Aspiration Catheters in STEMI Patients
Data indicate that the presence of an intracoronary thrombus in STEMI patients and distal embolization of thrombus debris
have a strong negative prognostic effect. Hence, there has been a lot of investigation and debate over the use of aspiration
of intracoronary thrombus in patients with STEMI since the late 2000s. In 2008, the very first large-scale single-center trial
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on this subject was conducted in the Netherlands (the Thrombus Aspiration During Primary Percutaneous Coronary
Intervention [TAPAS]) trial [7]. This randomized trial of 1071 patients with STEMI showed a statistically significant
improvement in myocardial blush grade, the primary end point of the study, in patients within the aspiration thrombectomy
arm. Although the primary end point of this study was improvement in myocardial blush grade and not mortality, the
30-day and 1-year follow-up study did show a significant reduction in the risk of mortality in patients who underwent
aspiration thrombectomy as opposed to PPCI. The rates of cardiac-related deaths and even nonfatal reinfarctions were also
significantly lower in the aspiration thrombectomy arm [8]. These unexpected findings expanded the use of aspiration
thrombectomy and opened doors to further trials and meta-analyses. Sardella and colleagues conducted a smaller,
prospective, randomized trial consisting of 175 patients with STEMI known as the EXPIRA trial [9]. The authors showed
that when thrombus aspiration was compared with conventional PPCI, aspiration thrombectomy led to high rates of
achieving TIMI (thrombolysis in myocardial infarction) myocardial blush grade of 2 or more and ST-segment resolution.
Using contrast-enhanced magnetic resonance imaging, they were also able to show reduced infarct size in patients who
underwent thrombus aspiration as opposed to conventional percutaneous coronary intervention (PCI). Instead of examining
the surrogate markers of clinical outcomes such as TIMI blush grade or ST-segment resolution, or relying on imaging
modalities such as cardiac magnetic resonance imaging or contrast echocardiography, several meta-analyses set out to
specifically examine all-cause mortality as their primary end point [10,11]. These meta-analyses were directly in line with
the results of the TAPAS trial. The use of aspiration thrombectomy was once again found to be superior to PPCI in STEMI
patients in terms of all-cause mortality as well as secondary clinical end points. These conclusions were incorporated in the
American College of Cardiology/American Heart Association (ACC/AHA) 2009 guidelines for management of patients
with STEMI [12]. The use of aspiration thrombectomy with PPCI in STEMI patients was endorsed with a class IIa
recommendation in these guidelines.
Given that TAPAS was a single-center trial and its finding of reduced mortality was unexpected, two larger-sized and
multicenter landmark trials were subsequently conducted that changed our outlook on aspiration thrombectomy. The first
of these two prospective trials was the Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction (TASTE)
trial, which consisted of over 7200 patients [13]. The second and even larger (n ¼ 10,732) trial was the Randomized Trial
of Primary PCI With or Without Routine Manual Thrombectomy (TOTAL) trial [14,15]. Unlike TAPAS, both TASTE
and TOTAL evaluated hard outcomes as their primary end points. Secondary end points measured by these trials
included repeat hospitalization, recurrence of myocardial infarction, stent thrombosis, target-vessel revascularization, and
cardiogenic shock. These studies showed no significant clinical benefit on primary and secondary end points (inclusive of
all-cause and cardi ac mortality) between the aspiration thrombectomy and the PPCI arms. With the neutral results of these
trials, as well as their 1-year follow-up reports, the field and the concept of routine use of aspiration thrombectomy changed
dramatically.
Furthermore, some studies investigated the utility of aspiration thrombectomy in other scenarios, such as in patients
with late presentation of STEMI and prolonged ischemic time with large thrombus burden. Desch and colleagues studied
the effect of thrombus aspiration on microvascular obstruction (MV O) as examined by cardiac magnetic resonance
imaging in patients presenting with subacute STEMI, defined as presentation between 12 and 48 h from symptom onset
[16]. It was hypothesized by the authors that, owing to delayed presentation and prolonged dwelling times, propensity
for larger thrombus burden that could respond successfully to intervention by aspiration catheters would be higher.
Unfortunately, the authors failed to demonstrate any benefit of thrombus aspiration compared with conventional PCI on
MVO in patients presenting with subacute STEMI. Concurrent use of upstream intracoronary glycoprotein IIb/IIIa
inhibitors along with aspiration thrombectomy was also studied in STEMI patients. The largest trial on this topic was the
trial of intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction
(INFUSE-AMI) [17]. Patients in this trial were randomized into intracoronary abciximab versus no intralesional
abciximab, along with being placed in the aspiration thrombectomy versus no thrombectomy arm of the study. There was
no statistically significant difference in the infarct size by cardiac MRI among the four arms. In a meta-analysis of 17
studies with 20,960 patients, there was no benefit of aspiration thrombectomy on clinical outcomes at a mean of 3.7 months
[18]. This analysis also showed that concurrent use of glycoprotein IIb/IIIa inhi bitors with aspiration thrombectomy or
ischemic time had no effect on clinical end points. In another meta-analysis of randomized trials assessing the effect of
aspiration thrombectomy on long-term outcomes, there was no difference in the risk of all-cause mortality, reinfarction
rates, stent thrombosis, or MACEs in the thrombus aspiration group at a mean of 12 months [19]. In light of these negative
findings, the earli er ACC guidelines on STEMI management were updated in 2015 and the routine use of aspiration
thrombectomy was downgraded to a class III recommendation, thereby remarking no benefit of routine use of aspiration
thrombectomy on clinical outcomes [20]. Most recently, in 2016, the investigators of TAPAS, TOTAL, and TASTE
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conducted a patient-level meta-analysis of greater than 18,000 patients with STEMI [21]. Although, as before, no
improvement in clinical outcomes was seen with aspiration thrombectomy as a routine strategy, 30-day outcomes of
patients with high thrombus burden (defined as TIMI thrombus grade >3) showed a trend toward improvement in clinical
outcomes. The reduction in all-cause and cardiovascular mortality was accompanied by a simultaneous increase in stroke
or transient ischemic attack (TIA) at 30 days. Therefore, it was hypothesized that even though the benefit of aspiration
thrombectomy may be significant only in patients with high thrombus burden, this benefit may be counterbalanced by the
increased propensity of this thrombus to embolize systemically and result in a stroke or TIA (Table 17.2).
Thrombus Aspiration in Patients With Non-STEMI
Although the use of aspiration thrombectomy in patients presenting with STEMI yielded disappointing results, researchers
and clinicians expressed curiosity regarding the utility of the aspiration catheter systems in patients with non-ST-segment
elevation myocardial infarction (NSTEMI). This curiosity was mainly driven by the notion that approximately 50%e70%
of all patients with NSTEMI have a small intracoronary thrombus in the culprit vessel. Previous studies had pointed out
that the incidence of the no-reflow phenomenon occurred in approximately 15%e40% of patients, depending on the
thrombus burden and intraprocedural thrombotic events [22]. The largest trial on this topic was the Thrombus Aspiration in
Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial, which was a
multicenter, randomized, prospective trial consisting of 460 patients. The primary end point of this study was assessment of
late MVO, which was measured via cardiac magnetic resonance imaging. This study showed that aspiration thrombectomy
in conjunction with conventional PCI yielded no improvement in MVO. As of this writing, the use of aspiration catheter
systems and this adjuvant technique is not recommended by the ACC for patients with NSTEMI.
Risks Associated With Aspir ation Thrombectomy
Although the idea behind the use of aspiration catheters was to prevent embolization from an intracoronary thrombus and
prevent microvascular damage, the procedure of aspiration thrombectomy itself is associated with risks. The most
worrisome risk is that of embolization of the thrombus from the coronary vasculature. Not only does distal embolization
cause downstream microvasculature obstruction, but peripheral systemic embolization of debris carries an increased risk of
strokes and other cardioembolic events. The procedure itself along with manipulation of the catheter over the guidewire
while maneuvering toward the target lesion, as well as prolonged intraprocedural times, all contribute to a heightened
risk and potential complications. In fact, the TOTAL trial demonstrated a significant increase in the risk of stroke with
aspiration thrombectomy [23]. In a meta-analysis of nine randomized trials with a primary focus on stroke, aspiration
thrombectomy was noted to be associated with a marginal increased risk of stroke, which was driven by the results of
the TOTAL trial [24]. A post hoc analysis from the TOTAL trial showed that a history of cerebrovascular accident or
TIA, essential hypertension, peripheral vascular disease, and older age were independent predictors of stroke in
patients undergoing aspiration thrombectomy; some of these predictors were numerically higher in the aspiration
thrombectomy arm.
Reasons for the Lack of Improvement in Clinical Outcomes
Based on the current data, the routine use of aspiration thrombectomy is not recommended in STEMI or NSTEMI patients.
The use of aspiration catheters in select cases, such as those with certain complex patient subgroups or intricate lesions, or
after failure of primary angioplasty, may still be warranted. Going forward, it will be prudent to study patients with
particularly high thrombus burden, because in this patient subgroup, thrombus aspiration may improve cardiovascular
mortality without a notable increased risk of stroke or TIA [21]. Due to the disappointing results of routine use of this
adjunctive therapy, several theories have evolved regarding the failure of aspiration thrombectomy in improving clinical
outcomes. One of the most plausible theories behind the lack of improvement in clinical outcomes has to do with the size
of intracoronary thrombus burden in STEMI patients. Although it is difficult, researchers who have tried to quantify
thrombus burden in STEMI patients have shown that almost 70% of all STEMIs were found to have less than mediumsized thrombus, which might not drive benefit from aspiration thrombectomy [25,26]. Second, when these aspiration
catheters are deployed to retrieve the thrombus debris, it is crucial to ensure that the apparatus is managed and handled with
care by a seasoned operator. Prior experience with aspiration catheters, the ability to swiftly guide them to the target lesion,
and efficient aspiration of the thrombus may make the difference between reaping benefits from this technology and
causing harm via distal embolization. A suboptimal technique used while operating an aspiration catheter may be the
reason aspiration thrombectomy has not been show n to improve clinical outcomes thus far [27]. One of the more obvious
TABLE 17.2 Landmark Trials on Aspiration Thrombectomy
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Study Year Patients (n) Follow-Up Duration, (months) Primary Outcome Combined Mortality or MI
TOTAL 2015 5033/5030 6 Composite of cardiac death, recurrent MI,
cardiogenic shock, NYHA class IV heart failure
TASTE 2013 3621/3623 1 All-cause mortality Favors aspiration thrombectomy
TROFI 2013 71/70 Hospital admission Myocardial reperfusion markers (Excluded)
MUSTELA 2012 50/104 12 Myocardial reperfusion markers and infarct size Favors PCI alone
IN FUSE-AMI 2012 229/223 1 Infarct size by MRI Favors aspiration thrombectomy
Ciszewski et al. 2011 67/70 Hospital admission Myocardial reperfusion markers (Excluded)
PIHRATE 2010 100/96 6 Myocardial reperfusion markers Favors aspiration thrombectomy
Liistro et al. 2009 55/56 6 Myocardial reperfusion markers Favors PCI alone
EXPIRA 2009 88/87 9 Myocardial reperfusion markers (Excluded)
VAMPIRE 2008 180/175 Hospital admission Myocardial reperfusion markers Favors aspiration thrombectomy
Export 2008 120/129 1 Myocardial reperfusion markers Favors aspiration thrombectomy
Chao et al. 2008 37/37 6 Myocardial reperfusion markers Favors PCI alone
TAPAS 2008 535/536 1 Myocardial reperfusion markers Favors aspiration thrombectomy
DEAR-MI 2006 74/74 Hospital admission Myocardial reperfusion markers (Excluded)
De Luca et al. 2006 38/38 6 Left-ventricular remodeling Favors aspiration thrombectomy
Kaltoft et al. 2006 108/107 1 Myocardial salvage by SPECT Favors aspiration thrombectomy
REMEDIA 2005 50/49 1 Myocardial reperfusion markers Favors aspiration thrombectomy
Favors aspiration thrombectomy
Aspiration Catheters and Protection Filters Chapter | 17 253
MI, myocardial infarction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; SPECT, single-photon emission computed tomography.
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